Hypoglycemia and Autonomic Nervous System Function- B2

Description

We will study the effect of hypoglycemia (low blood sugar) on baroreflex sensitivity in participants with well controlled type 2 diabetes.

Study Start Date

September, 25 2017

Estimated Completion Date

December 2018

Interventions

  • Other: Hyperinsulinemic Hypoglycemic Clamp

Study ID

Brigham and Women's Hospital -- 2004P001233-B2

Status

Recruiting

Trial ID

NCT03422471

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

14

Sponsor

Brigham and Women's Hospital

Inclusion Criteria

  • Males and females age 18 to 55 years
  • Type 2 Diabetes Mellitus controlled by diet, exercise and non-insulin glycemic control agents (metformin, thiazolidinediones, sulfonylureas, dipeptidyl peptidase-4 inhibitors, sodium-glucose co-transporter 2 inhibitors, alpha-glucosidase inhibitors or glucagon-like peptide-1 receptor agonist) or basal insulin at doses less than or equal to 0.3 units/ kg per day.

Exclusion Criteria

  • Hemoglobin A1c > 9% for type 2 diabetes
  • Recurrent hypoglycemic episodes within the past month
  • BMI < 25 or > 42 (Type 2 diabetes only)
  • Pregnancy
  • Lactation
  • Clinically significant coronary artery, cerebrovascular, or peripheral vascular disease, or presence of systemic illness that might affect autonomic function. Such illnesses include congestive heart failure, renal, pulmonary, hepatic disease, anemia, malignancies, untreated thyroid disease, and alcoholism.
  • Current major depressive illness
  • In all subjects, any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded.
  • Known hypersensitivity to nitroglycerin, nitroprusside and/or phenylephrine.
  • Blood pressure > 160/100 mmHg (applies to participants with T2 diabetes)
  • Creatinine > 1.5 mg/dL
  • Serum potassium >5.2 mmol/L
  • Estimated GFR < 50 mL/min
  • Use of Viagra, Cialis, and similar drugs within 72 hours of admission.
  • Use of beta-blockers or mineralocorticoid receptor antagonists

Gender

All

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Rebecca Easly BA 617-525-7357 reasly@bwh.harvard.edu

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.